TEAMWork App for Breast Cancer

Recruiting at 18 trial locations

Overseen By Victoria Blinder, M.D., M.Sc.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Stage 0, Stage IV, Metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

546 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app designed to help breast cancer patients manage their jobs during treatment. Researchers aim to evaluate the effectiveness of the app, called the TEAMWork App (Talking to Employers And Medical staff about Work), in assisting patients with discussions about their work situation with employers and doctors. Participants will either use the app or receive a paper booklet containing similar information. Suitable candidates for this trial are women who have completed chemotherapy for stage I-III breast cancer, are employed, and can use a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for managing work-life balance during cancer treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the TEAMWork App is safe for breast cancer patients to use?

Research shows that the TEAMWork app helps breast cancer patients discuss work-related issues during treatment. As a mobile app providing information and advice, it poses no risk of physical harm, unlike drug treatments. Studies have not identified any negative effects from using the app, as it primarily offers resources and communication tools.

This study tests the app's features to evaluate their effectiveness and potential improvements. The aim is to enhance usability and helpfulness, not to assess health risks. Since the app is not a medical treatment, it is generally considered safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TEAMWork App for breast cancer patients because it offers a unique, interactive approach to managing workplace accommodations and clinical communications. Unlike traditional paper-based information booklets, the app provides multimedia features like videos with actors demonstrating how to request accommodations from employers, making the information more engaging and practical. Additionally, the app allows users to take private notes and access templates and legal resources directly, offering a personalized and confidential experience to help navigate both workplace and medical challenges effectively.

What evidence suggests that the TEAMWork App is effective for helping breast cancer patients maintain employment?

Research has shown that the TEAMWork app, one of the interventions in this trial, can be a useful tool for breast cancer patients facing work-related challenges. Participants in this trial may receive the app, which offers advice on communicating with employers and doctors about balancing work and treatment. Early results suggest that using this app helps patients feel more prepared and confident when discussing workplace adjustments. It includes videos, templates, and legal information to support these discussions. While detailed evidence on its effectiveness is still being gathered, the app aims to reduce the stress of managing work and cancer treatment. ^{1 2 3 4 6}

Who Is on the Research Team?

Victoria Blinder, M.D., M.Sc.

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for breast cancer patients aged 18-64, who are currently employed and about to start or already receiving chemotherapy for stage I-III breast cancer. They must be able to give consent in English or Spanish, have a smartphone, and be comfortable using it. Excluded are those with stage 0 (DCIS only) or stage IV (metastatic) breast cancer, those with recurrent metastatic disease, and participants in related social determinants of health studies.

Inclusion Criteria

I am a woman.

Patient Usability Testing Inclusion Criteria: Able to use and read a smartphone (iPhone or Android)

I can give informed consent in English or Spanish.

Exclusion Criteria

My breast cancer is not just in the ducts (not stage 0).

RCT Exclusion Criteria: Participants or family members who are participating in MSK IHCD studies related to social determinants of health

My breast cancer has not spread to distant parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the TEAMWork app or receive an information booklet to help manage employment during breast cancer treatment

2 years

Follow-up

Participants are monitored for employment status and effectiveness of the app in improving communication and job retention

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Information Booklet
• TEAMWork App

Trial Overview The study tests the TEAMWork App against an information booklet. The app aims to help breast cancer patients manage their employment during treatment by providing advice on communicating with employers and medical staff about work-related needs.

How Is the Trial Designed?

Group I: TEAMWork App Experimental Treatment 1 Intervention

The 2-pronged approach of the intervention is operationalized through 2 menus, 1 focused on interactions with the employer and the other with the clinic team. Each menu has a list of features from which participants can choose to learn about a particular topic. A "My notes" button allows participants to take notes directly on the app. These notes will not be available to the research team, such that participants may use the tool without concerns about privacy. The workplace accommodations menu includes sample videos using trained actors to demonstrate how to approach an employer to request accommodations. Additional features include suggestions for accommodations that may be helpful, templates for letters participants can use when requesting accommodations, links to relevant websites, information about legal protections, and contact information for lawyers and firms that provide pro bono assistance.

Group II: Information Booklet (control) Active Control 1 Intervention

Participants will receive a booklet that includes the information in the app that can practicably be converted to paper. These participants will not have access to the multimedia aspects of the intervention, such as the videos, but they will have all of the relevant information in the app described above, including suggestions for accommodations, written templates for letters, links to websites, information about legal protections, and contact information for pro bono legal assistance. The booklet will also contain information about chemotherapy, radiation therapy and surgery, recommendations for management of common symptoms, and advice for communicating with the clinic team. The information booklet will be provided entirely on paper, although participants may independently access websites recommended in the booklet. The booklet content will mirror the app with regard to cultural responsiveness and appropriateness for different job types and characteristics.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

The mobile app 'AMOR Mama' was evaluated by 8 healthcare professionals and was found to be suitable for guiding and monitoring breast cancer patients undergoing radiation therapy, with a high concordance index of 80% for most features.

The app's usability for users of different educational levels was the only area needing improvement, indicating that while the app is effective, further refinements could enhance accessibility for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App (AMOR Mama) for Women With Breast Cancer Undergoing Radiation Therapy: Functionality and Usability Study. Cruz, FOAMD., Faria, ET., Ghobad, PC., et al.[2021]

The TeamSTEPPS program, inspired by safety practices from high-risk industries, aims to enhance patient safety in healthcare by promoting teamwork and effective communication among healthcare professionals.

Evidence shows that implementing TeamSTEPPS can improve safety and patient outcomes by shifting healthcare workers' focus from individual expertise to collaborative team performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The TeamSTEPPS Approach to Safety and Quality. Epps, HR., Levin, PE.[2022]

The You CAN campaign, designed to enhance teamwork in oncology care, successfully reached 32% of patients in the ambulatory clinic, indicating its feasibility in engaging patients and families in their care.

While there was no significant change in self-reported use of teamwork techniques, 39% of patients exposed to the campaign reported a change in their behavior, suggesting the initiative had a positive impact on patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The You CAN campaign: teamwork training for patients and families in ambulatory oncology. Weingart, SN., Simchowitz, B., Eng, TK., et al.[2019]

Out of 776 health apps identified for supporting breast cancer treatment and aftercare, only 12 were classified as partially recommended and just 3 as recommended, indicating that most apps do not meet quality standards for patient support.

The evaluation criteria included user assessments and scientific benefits, highlighting that while some apps may offer potential benefits for breast cancer patients, the majority lack sufficient quality and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Applications Available in Germany Supporting Breast Cancer Patients During Treatment and Aftercare: a Systematic Review. Gomm, SIM., Ebner, FK., Lukac, S., et al.[2023]

The implementation of the 'Glass Door' communication tool in a pediatric intensive care unit significantly increased daily patient goal setting from 22.9% to 90.7%, demonstrating its effectiveness in enhancing communication and collaboration among healthcare teams.

Post-implementation, the 'Glass Door' not only improved the efficiency of patient rounds, reducing time spent from 11.7 minutes to 7.5 minutes per patient, but also increased goal discussions during rounds from 40.1% to 58.5%, indicating its positive impact on team dynamics and patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Daily Patient Goal-Setting and Team Communication: The Liber8 Glass Door Project. Jones, IGR., Friedman, S., Vu, M., et al.[2023]

Implementing a customized TeamSTEPPS® training program significantly improved staff perceptions of teamwork and communication in a healthcare setting, addressing a key factor in patient safety.

The project demonstrates that TeamSTEPPS is a practical and cost-effective approach to enhancing communication and teamwork, which are critical in preventing patient sentinel events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Patient Safety: Results of a TeamSTEPPS® Initiative. Gaston, T., Short, N., Ralyea, C., et al.[2016]

A review of 101 breast cancer-related mobile apps revealed that while they provide valuable educational content, the majority focus on outdated practices like breast self-examination, which is no longer recommended as a primary screening method.

Most apps did not adhere to usability and health literacy standards, indicating a need for improvement in app design to ensure they are accessible and informative for diverse populations, particularly in areas like survivorship and end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content, Usability, and Utilization of Plain Language in Breast Cancer Mobile Phone Apps: A Systematic Analysis. Ginossar, T., Shah, SF., West, AJ., et al.[2023]

A systematic evaluation of 707 breast cancer apps available in Turkey revealed a mean quality score of 3.4 on the Mobile App Rating Scale (MARS), indicating that while these apps provide basic information, they lack personalized management tools for prevention and early detection.

The study highlights the need for improved e-health apps that incorporate evidence-based content and support from healthcare professionals to better assist breast cancer survivors in managing their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer-related apps in Google Play and App store: evaluate their functionality and quality. Aydin, A., Gursoy, A.[2023]

Out of 123 cancer-related smartphone applications analyzed, 50% provided general cancer information, but only 10% cited their content sources, raising concerns about the reliability of the information provided.

Only 3% of the apps had content that was evaluated by health providers, indicating a lack of professional oversight which could affect the quality and safety of the information available to users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone apps for cancer: A content analysis of the digital health marketplace. Charbonneau, DH., Hightower, S., Katz, A., et al.[2022]

A quality improvement project at a small rural hospital showed that implementing a customized TeamSTEPPS training program significantly improved staff attitudes towards teamwork and communication skills.

The training led to better incorporation of team-based tools into daily practice, highlighting TeamSTEPPS as an effective method for enhancing collaboration among various healthcare disciplines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of TeamSTEPPS Training With Rural Hospital Staff: A Quality Improvement Project. Prochnow, L., Tschannen, D.[2023]

The implementation of the TeamSTEPPS teamwork system in an academic interventional ultrasound program led to significant improvements in teamwork climate scores, increasing from a mean of 67.9 to 87.8, and safety climate scores, increasing from 76.5 to 88.3, based on surveys from 64 healthcare professionals.

Key improvements were noted in communication and role clarification among team members, indicating that the TeamSTEPPS model can effectively enhance teamwork and safety in imaging practices, similar to its success in other medical fields.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice and quality improvement: successful implementation of TeamSTEPPS tools into an academic interventional ultrasound practice. Gupta, RT., Sexton, JB., Milne, J., et al.[2014]

Effective teamwork and communication among healthcare workers are crucial for ensuring patient safety, especially in high-risk situations like those handled by rapid response teams (RRT).

This study utilized live observations and team member ratings to assess teamwork within RRTs, highlighting the need for targeted communication training to improve team performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Observed and self-perceived teamwork in a rapid response team. Beebe, P., Bawel-Brinkley, K., O'Leary-Kelley, C.[2015]

The implementation of the TeamSTEPPS teamwork improvement concept in a maternity ward led to significant increases in patient safety culture scores in three key areas: Supervisor/Manager Expectations and Actions Promoting Safety, Teamwork Within Units, and Nonpunitive Response to Errors, with improvements noted from 2015 to 2016.

In contrast, a control ward experienced a decrease in scores in one dimension, highlighting the effectiveness of TeamSTEPPS in enhancing safety culture in high-risk environments like maternity wards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of TeamSTEPPS on patient safety culture in a Swiss maternity ward. Staines, A., Lécureux, E., Rubin, P., et al.[2021]

Formal teamwork training programs, like TeamSTEPPS and the Healthy Workplace Intervention, have been shown to reduce errors in healthcare settings, improve nurse satisfaction, and lower staff turnover rates.

Implementing and supporting teamwork training within hospital systems is essential for creating healthier workplaces that enhance patient safety and care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teamwork: building healthier workplaces and providing safer patient care. Clark, PR.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03572374

Talking to Employers and Medical Staff About Breast ... The app provides advice for patients to use when having conversations about breast cancer with their employers and their doctors. The app is called TEAMWork ( ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9527379/

An interactive mobile application versus an educational ... TEAMWork is a two-pronged intervention; it includes two “menus,” one of which focuses on interactions with the employer and the other with the oncology ...

3. facingourrisk.org facingourrisk.org/research-clinical-trials/study/86/talking-to-employers-and-medical-staff-about-breast-cancer-treatment-and-your-job

Talking to Employers and Medical Staff About Breast ... The goal of this study is to improve a tool that helps cancer patients navigate work-related issues. Researchers are testing an early version of a mobile app ...

4. withpower.com withpower.com/trial/phase-breast-neoplasms-5-2018-b2b42

TEAMWork App for Breast Cancer The app aims to help breast cancer patients manage their employment during treatment by providing advice on communicating with employers and medical staff about ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36192754/

a randomized controlled trial - PubMed - NIH This study is a randomized controlled trial to evaluate the app as a job-retention tool compared to a control condition that provides the app content in an ...

6. cancer.gov cancer.gov/clinicaltrials/NCI-2018-01426

TEAMWork Mobile Application in Helping with Talking to ... The TEAMWork mobile application may help doctors learn more about how being treated for breast cancer affects patients' employment, and how to help patients ...